REDUCE LAP-HF TRIAL
- Conditions
- Heart Failure
- Interventions
- Device: IASD
- Registration Number
- NCT01913613
- Lead Sponsor
- Corvia Medical
- Brief Summary
The objective of this clinical study is to evaluate the safety and performance of the IASD System II in the treatment of heart failure patients with elevated left atrial pressure, who remain symptomatic despite appropriate medical management.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 64
-
Chronic symptomatic Heart Failure (HF) documented by one or more of the following:
- New York Heart Association (NYHA) Class II/III/ambulatory class IV symptoms (Paroxysmal nocturnal dyspnea, Orthopnea, Dyspnea on mild or moderate exertion) at screening visit; or signs (Any rales post cough, Chest x-ray demonstrating pulmonary congestion,) within past 12 months;
- One hospital admission for which HF was a major component of the hospitalization within the 12 months prior to study entry (transient heart failure in the context of myocardial infarction does not qualify);
- On-going management with recommended heart failure medications and comorbidities for several months according to the guidelines (2012 ESC Guidelines for diagnosis and Treatment of Acute and Chronic Heart Failure).
-
Age ≥ 40 years old
-
Left ventricular ejection fraction (obtained by echocardiography) ≥ 40%
-
Elevated left ventricular filling pressures with a gradient compared to CVP documented by :
- PCWP or LVEDP at rest ≥ 15 mmHg, and greater than CVP, OR
- PCWP during supine bike exercise ≥ 25mm Hg, and CVP < 20 mm Hg
Key
-
Severe heart failure defined as:
-
ACC/AHA/ESC Stage D heart failure, Non-ambulatory NYHA Class IV HF;
-
Fick Cardiac Index < 2.0 L/min/m2
-
Requiring inotropic infusion (continuous or intermittent) within the past 6 months
-
Patient is on the cardiac transplant waiting list 4. Inability to perform 6 Minute Walk Test 5. Known significant coronary artery disease (stenosis >70%) 6. History of stroke, transient ischemic attack (TIA), deep vein thrombosis (DVT), or pulmonary emboli within the past 6 months 7. Known severe carotid artery stenosis (> 70%) 8. Presence of significant valve disease defined by echocardiography as: a) Mitral valve regurgitation defined as grade >2+ MR b) Tricuspid valve regurgitation defined as grade ≥ 2+ TR; c) Aortic valve disease defined as ≥ 2+ AR or moderate AS
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Treatment IASD Treatment with the IASD device
- Primary Outcome Measures
Name Time Method MACCE 6 months subjects who experience major adverse cardiac and cerebrovascular events (MACCE) defined as death, stroke, MI; or subjects who experience a systemic embolic event (excluding pulmonary thromboembolism)
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (26)
Fourth Military Hospital
🇵🇱Wroclaw, Poland
Medizinische Universität Graz
🇦🇹Graz, Austria
OLVZ Aalst
🇧🇪Aalst, Belgium
The Prince Charles Hospital
🇦🇺Brisbane, Australia
St. Vincent Hospital
🇦🇺Sydney, Australia
Homolka Hospital
🇨🇿Prague, Czechia
St Antonius Ziekenhuis
🇳🇱Nieuwegein, Netherlands
King's College
🇬🇧London, United Kingdom
Universtitaät Kliniku Schlewig Holstein
🇩🇪Kiel, Germany
Universitatklinikum Duseldorf
🇩🇪Dusseldorf, Germany
Klinikum der Universität Munchen
🇩🇪Munich, Germany
Royal Brompton/Harefield Trust
🇬🇧Harefield, United Kingdom
David Kaye
🇦🇺Melbourne, Australia
CHRU de Lille
🇫🇷Lille, France
Allgemeines Krankenhaus Univesitäts Kliniken
🇦🇹Vienna, Austria
Hôpital Bichat
🇫🇷Paris, France
Georg-August-Universitat
🇩🇪Gottingen, Germany
Golden Jubilee Hospital
🇬🇧Glasgow, United Kingdom
Asklepios Klinik St George
🇩🇪Hamburg, Germany
Rigshospitalet
🇩🇰Copenhagen, Denmark
Hôpital Rangueil
🇫🇷Toulouse, France
CHU de Nantes
🇫🇷Nantes, France
Hôpital La Pitié Salpétrière
🇫🇷Paris, France
Cardiologicum CRC
🇩🇪Hamburg, Germany
University of Heidelberg
🇩🇪Heidelberg, Germany
Auckland City Hospital
🇳🇿Auckland, New Zealand